FDA Updates ‘Healthy’ Labeling Rule: What Food Businesses Need to Know

New FDA Regulations Redefine ‘Healthy’ Claims on Food Labels

The U.S. Food and Drug Administration (FDA) has finalised new regulations for “healthy” nutrient content claims, introducing stricter labelling standards for food products. These rules, effective February 25, 2025, mark a major shift in how food manufacturers can market products, focusing on overall nutritional value rather than individual nutrient fortification.

Companies have until February 25, 2028, to comply, but failure to meet these standards could result in regulatory enforcement actions, product misbranding claims, and private litigation under consumer protection laws.

What’s Changing in the ‘Healthy’ Claim Definition?

For the first time, FDA regulations limit added sugars, sodium, and saturated fats in products marketed as “healthy.” The new rules require that foods:

• Contain minimum amounts of key food groups (vegetables, fruits, dairy, grains, protein, or oils).

• Meet specific limits on added sugars, sodium, and saturated fats.

• Reflect scientific dietary guidelines, rather than relying on nutrient fortification alone.

Under these updated standards, foods like salmon, whole grains, and nuts may now qualify as “healthy,” while fortified processed foods, sweetened yoghurts, and high-sugar cereals may no longer meet the criteria.

Legal Risks & Compliance Challenges for Food Businesses

Failure to comply with the new FDA “healthy” claim standards could expose food manufacturers and distributors to several legal risks, including:

• FDA enforcement actions – Non-compliant products may be classified as misbranded, leading to warning letters, product seizures, or facility inspections.

• Increased litigation risks – Private litigants and consumer advocacy groups may file class-action lawsuits against companies that misuse the “healthy” label, alleging violations of federal and state consumer protection laws.

• Reformulation & labelling costs – Businesses may need to adjust product recipes, marketing materials, and packaging to align with FDA requirements before the compliance deadline.

How Food Companies Can Prepare

To ensure compliance before the 2028 enforcement deadline, businesses should:

• Audit current product labels to assess whether they meet the new FDA “healthy” standards.

• Review ingredient formulations to reduce added sugars, sodium, and saturated fats where necessary.

• Enhance compliance monitoring with internal recordkeeping and regulatory oversight.

• Prepare for potential litigation risks related to mislabeling and false advertising claims.

How Our Firm Can Help

With me, I assist food manufacturers, distributors, and retailers in navigating FDA compliance and mitigating legal risks. I can provides:

✔ Regulatory compliance guidance – Ensuring adherence to FDA food labelling laws and nutrient content claim regulations.
✔ Risk assessments & product labelling audits – Helping businesses evaluate whether their products meet the new “healthy” criteria.
✔ Litigation defence – Representing companies in class-action lawsuits and regulatory disputes over food labelling claims.
✔ Strategic compliance planning – Assisting with labelling updates, reformulation strategies, and FDA enforcement matters.

📩 Contact me today to ensure your food labelling strategy aligns with FDA regulations and avoids costly legal challenges.

David Orchard | Lawyer

+44 743 789 4552